El-005N-G6-Y
by Zhenjiang Assure Medical Equipment Co., Ltd
Ref EL-005Model EL-001,EL-001B,EL-003,EL-004,EL-005N-G6-Y
Active
CE MDR 510(k)
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k) 510(k) | NumberK251159 | Date22 Dec 2025 | StatusActive |
| European Union | CE/MDR EUDAMED | Number697423110ASSUREPWCJ 06974231101963 | Date25 Dec 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls found in the data synced 24 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- United States
- European Union
Specification
- Device Name
- Power wheelchair
- Model / Reference
- EL-001, EL-001B, EL-003, EL-004, EL-005N-G6-Y, EL-005
- Primary DI / UDI-DI
- 06974231101963
- Basic UDI-DI
- 697423110ASSUREPWCJ
- EMDN Code
- Y122127 Electric wheelchairs
- Device Class
- Class I
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000001076
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from Zhenjiang Assure Medical Equipment Co., Ltd
See all devices from Zhenjiang Assure Medical Equipment Co., Ltd →
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No